The present invention relates generally to systems and methods for managing patient care in a health care facility, and more particularly, to systems and methods for analyzing medical treatment data to determine institutional guidelines for medical treatments provided to patients.
Medication errors, that is, errors that occur in the ordering, dispensing, and administration of medications, regardless of whether those errors caused injury or not, are a significant consideration in the delivery of healthcare in the institutional setting. Additionally, adverse drug events (“ADE”), which are a subset of medication errors, defined as injuries involving a drug that require medical intervention, and representing some of the most serious medication errors, are responsible for a number of patient injuries and death. Healthcare facilities continually search for ways to reduce the occurrence of medication errors. Various systems and methods are being developed at present to reduce the frequency of occurrence and severity of preventable adverse drug events (“PADE”) and other medication errors. In the administration of medication, focus is typically directed to the following five “rights” or factors: the right patient, the right drug, the right route, the right amount, and the right time. Systems and methods seeking to reduce ADE's and PADE's should take these five rights into consideration.
In many hospitals and clinical laboratories, a bracelet device having the patient's identification, such as his or her name printed thereon, is affixed to a patient upon admittance to the facility in order to identify the patient during his or her entire stay. Despite this safeguard, opportunities arise for patient identification error. For example, when a blood sample is taken from a patient, the blood sample must be identified by manually transcribing the patient's name and other information from the patient's identification bracelet. In transferring the patient's name, a nurse or technician may, instead of actually reading the patient's bracelet, miscopy the name or may rely on memory or a different data source. Moreover, manually transferring other information such as parameters for configuring an infusion pump to dispense medication may result in errors that reduce the accuracy and/or effectiveness of drug administration and patient care. This may result in an increased duration of treatment with an attendant increase in cost.
Hospitals and other healthcare institutions continuously strive to provide quality patient care. The possibility of medical errors, such as where the wrong patient receives the wrong drug at the wrong time, in the wrong dosage, or even where the wrong surgery is performed, is a significant concern for all healthcare facilities. Many prescription drugs and injections are identified merely by slips of paper on which the patient's name and identification number have been hand-written by a nurse or technician who is to administer the treatment. For a variety of reasons, such as the transfer of patients to different beds and errors in marking the slips of paper, the possibility arises that a patient may be given an incorrect treatment. This could be prevented by using an automated system to verify that the patient is receiving the correct care. Various solutions to these problems have been proposed, such as systems that use bar codes to identify patients and medications, or systems allowing the bedside entry of patient data. While these systems have advanced the art significantly, even more comprehensive systems could prove to be of greater value.
Delivery, verification, and control of medication in an institutional setting have traditionally been areas where errors can occur. In a typical facility, a physician enters an order for a medication for a particular patient. This order may be handled either as a simple prescription slip, or it may be entered into an automated system, such as a physician order entry (“POE”) system. The prescription slip or the electronic prescription from the POE system is routed to the pharmacy, where the order is filled, so that the medication can be provided to the patient. Typically, pharmacies check the physician order against possible allergies of the patient and for possible drug interactions in the case where two or more drugs are prescribed, and also check for contra-indications. Depending on the facility, the medication may be identified and gathered within the pharmacy and placed into a transport carrier for transport to a nurse station. Once at the nurse station, the prescriptions are again checked against the medications that have been identified for delivery to ensure that no errors have occurred.
Typically, medications are delivered to a nurse station in a drug cart or other carrier that allows a certain degree of security to prevent theft or other loss of medications. In one example, the drug cart or carrier is divided into a series of drawers or containers, each container holding the prescribed medication for a single patient. To access the medication, the nurse must enter the appropriate identification to unlock a drawer, door, or container. In other situations, inventories of commonly-used drugs may be placed in a secure cabinet located in an area at or close by a nurse station. This inventory may contain not only topical medications but oral, IM-, and IV-delivered medications as well. Nurse identification and a medication order number are typically required to gain access to the cabinet.
The nurse station receives a listing of drugs to be delivered to patients at intervals throughout the day. A nurse or other care-giver or other qualified person reads the list of medications to be delivered, and gathers those medications from the inventory at the nurse station. Once all of the medications have been gathered for the patients in the unit for which the nurse station is responsible, one or more nurses then take the medications to the individual patients and administer the dosages.
Common to all of these systems is the nurse who delivers the medication. The nurse is central to the process of verifying that the right medication is given to the right patient in the right dosage at the right time at the point of care. No other person in the facility is situated as well as the nurse delivering the medication to ensure or verify that the appropriate drug is being given to the appropriate patient.
Such a system works well to verify that patients are receiving the appropriate drug when drugs are delivered orally, but the system may not be capable of thoroughly verifying that the appropriate medication regimen is being delivered to a patient in the case where IV drugs are being delivered. For example, a nurse may carry an IV bag to a particular patient area, hang the bag, program an infusion pump with appropriate treatment parameters, and begin infusion of the medication. The applicable hospital control system, such as the pharmacy information system, may not know that the patient has received the medication, and if the information is lost somewhere, the possibility exists of medicating the patient twice. Thus, there may be a break in the link of verification that the medication is being properly delivered to the patient if an event occurs resulting in a deviation from the desired treatment parameters.
Moreover, even where the right medication arrives at the right patient for administration, incorrect administration of the medication may occur where the medication is to be administered using an automated or semi-automated administration device, such as an infusion pump, if the automated device is programmed with incorrect medication administration parameters. For example, even where the medication order includes the correct infusion parameters, those parameters may be incorrectly entered into an infusion pump, causing the infusion pump to administer the medication in a manner that may not result in the prescribed treatment.
One attempt at providing a system with built-in safeguards to prevent the incorrect entry of treatment parameters utilizes a customizable drug library which is capable of monitoring the parameter entry process and interacting with the care-giver should an incorrect entry or an out of range entry be attempted. In such a case, an alert is communicated to the care-giver that the parameter entered is either incorrect or out of a range established by the institution where care is being provided. The institutionally established parameters are typically created by polling doctors in the institution as to acceptable entries for the parameters. For instance, doctors may be polled as to the dosage ranges they prescribe for particular drugs. The doctors' input is used as the basis for the institution's customized practice guidelines which are incorporated into the drug library. Even though these customized drug libraries have provided a significant advance in the art for avoiding medication errors, there still exists some inaccuracy in the method used for customizing the dosage limits and other parameters in the drug libraries. Institutionally established guidelines compiled from polling doctors are often not entirely consistent with the actual best practice at the institution, and may result in, for example, dosage range limits that are set too loosely or too tightly compared to the actual best practice. Therefore, it would be advantageous to provide a more accurate system for creating institutional guidelines to ensure medical treatment at the institution is consistent with the actual best practice. It would also be advantageous to provide a system that automatically evaluates and/or adjusts guidelines in accordance with changing best practice procedures over time without requiring further polling of doctors.
Various methods have been used to record all of the activities surrounding the delivery of a treatment regimen, such as providing an infusion pump with a memory dedicated to storing a record of events related to a particular treatment. For example, in one system, an infusion pump has a memory in which treatment information, including treatment parameters, patient identification, care-giver identification and other information are stored for later retrieval. Alternatively, the infusion pump may be programmed to store information related to only certain events occurring during treatment delivery, such as the occurrence of alarms or other alerts. Such systems typically require that the infusion pump be connected to a separate computer using an appropriate communication protocol to query the memory and download a copy of the stored events for analysis. Such information retrieval requires that each infusion pump be connected and analyzed separately, requiring large expenditures of skilled technician time. Additionally, the information retrieved from the memory is generally in a raw form that requires additional analysis before it is useful to an institution to determine safe and effective institutional guidelines or to evaluate preexisting institutional guidelines. Further, the systems that record only errors or particular “events” are not capable of compiling and analyzing data associated with other medical treatments that are consistent with best practice, and thus cannot provide any feedback as to guidelines, rules or limits that are set too loosely and do not generate any errors. These systems also do not automatically analyze the medical treatment data and create, or adjust, guidelines based on the analysis.
There are also systems which expand the customized drug library to include rule sets that represent rules and/or algorithms that modify a parameter based upon data obtained from other sources in the network, such as patient age, body weight, medical history or measurements from vital signs monitoring devices. However, there is no such system that provides rule sets which may be automatically adjusted based on an analysis of actual practice at the institution and trend analysis, and which also takes into account patient outcomes as a result of medical treatments in determining and/or adjusting the rule sets.
Hence what has been recognized as a need, and has heretofore been unavailable, is an integrated, modular system for tracking and controlling patient care which includes the collection and analysis of data relating to medical treatments provided to patients to create and/or adjust institutional guidelines or rules sets for medical treatments to achieve accurate, reliable, efficient, and cost-effective delivery of health care to patients. Such a system would also be capable of sending a report containing the analysis to personnel within the institution for use in updating the guidelines stored in a medical administration device and/or automatically updating preestablished guidelines or rule sets stored in the device. The system would further be capable of taking into account patient outcomes in analyzing the medical treatment data to determine the guidelines or rule sets. The invention fulfills this need and others.